Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine (ATOM)

Trial details

Who runs it

Rigshospitalet

Trial code

EU 2024-517128-21-02

Record updated

2025. január 29.

Original description

The percentage of subjects who become pain free at 2 hours(h) after treatment, before the use of any rescue medication is the primary measure of efficacy.Read full original descriptionShow less

A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine (ATOM).

The percentage of subjects who become pain free at 2 hours(h) after treatment, before the use of any rescue medication is the primary measure of efficacy.

Inclusion: History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the ICHD-33 criteria based on medical records and/or patient selfreport; Subject has provided informed consent prior to initiation of any study-specific activities/procedures; Aged 18 to 65 years upon entry into screening; Not more than 12 attacks per month with moderate to severe headache pain in each of the previous 3 months.

Exclusion: Current preventive treatment with monoclonal antibodies targeting calcitonin gene related peptide (CGRP) or CGRP receptors, or current use of small-molecule CGRP receptor antagonist (e.g. erenumab, fremanezumab, galcanezumab, atogepant or rimegepant); Changes in treatment with Selective serotonin reuptake inhibitors (SSRI) or serotonin norepinephrine reuptake inhibitors (SNRI) within the last two months; Use of the following medication within 30 days prior to screening: o Strong and moderate cytochrome P450 3A4 (CYP3A4) inhibitors, including but not limited to systemic (oral/IV) itraconazole, ketoconazole, fluconazole; erythromycin, clarithromycin, telithromycin; diltiazem, verapamil; aprepitant; cyclosporine; nefazodone; cimetidine; quinine; and HIV protease inhibitors o Strong and moderate CYP3A4 inducers, including but not limited to barbiturates (eg, phenobarbital and primidone), systemic (oral/IV) glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, rifampin, rifabutin, and St. John’s wort o Inhibitors of the BCRP (breast cancer resistance protein) transporter (eg, rifampicin) o Drugs with narrow therapeutic margins (eg, digoxin, warfarin); Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product; Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product; Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per months in the previous 3 months; Required hospital treatment of a migraine attack 3 or more times in the previous 6 months; Has a history of any prior gastrointestinal conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded; Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer; History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion; History of cluster headache or hemiplegic migraine headache; Has a history of migraine aura with diplopia or impairment of levels of consciousness, hemiplegic migraine, or retinal migraine; Has a chronic non-headache pain condition requiring daily pain medication; Greater than 50 years of age at migraine onset; Start of new preventive migraine treatment within the last two months; Change in dosage of ongoing preventive migraine treatment within the last two months; Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test; Evidence of current pregnancy or breastfeeding per subject self-report or medical records; Subject has known sensitivity to any of the products or components to be administered during dosing; Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge; Inability to differentiate between migraine from other headaches; The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior.

EU CTIS 2024-517128-21-02